UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047247 |
|---|---|
| Receipt number | R000053864 |
| Scientific Title | Cognitive training via conversation support to community-living older adults -2 |
| Date of disclosure of the study information | 2022/03/22 |
| Last modified on | 2023/03/22 09:19:35 |
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Basic information
Public title
Cognitive training via conversation support to community-living older adults -2
Acronym
Cognitive training via conversation support to community-living older adults -2
Scientific Title
Cognitive training via conversation support to community-living older adults -2
Scientific Title:Acronym
Cognitive training via conversation support to community-living older adults -2
Region
| Japan |
Condition
Condition
Healthy older adults with subjective cognitive concern
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the effects of the remote conversation support application on cognitive, psychological, and social aspects in healthy older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outcomes are measured through a cognitive test that was conducted telephonically pre-and post-intervention (after 12 weeks).
- The Japanese version of Telephone Interview for Cognitive Status (TICS-J)
- Digit span
- Verbal fluency (semantic fluency and phonemic fluency)
Key secondary outcomes
Secondary outcomes are social and psychological indicators and are evaluated using questionnaires, pre-and post-intervention (after 12 weeks).
- Multidimensional Scale of Perceived Social Support
- Geriatric Depression Scale
- UCLA Loneliness Scale
- WHO-5 Well-being Index
- Health Utilities Index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention program provides group conversation via an application from the participant`s home. Prior to each session, a photo taken by the participant, on a smartphone or tablet, as per a particular theme, are uploaded on the application. During the intervention session, participants are involved in a remote group conversation via the application. Each participant presents their photos on the application, followed by a question and answer session. The participants receive weekly sessions for 30 minutes for 12 weeks.
Interventions/Control_2
Control group participants are required to watch remote health education videos related to health and successful aging once a week for 12 weeks. Each video is approximately 30 minutes long.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Age >= 65 years
-Scored >= 33 points in the TICS-J examination
-With subjective memory complaints
-Can intervene and perform necessary tests on the designated date
-Provided consent in writing for participating in the trial
Key exclusion criteria
-Neurological impairment known to affect the central nervous system
-Any serious complicating disorder
-History of serious head injury
-Any disease or medication known to affect the central nervous system
-History of stroke
-Requiring long-term care
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Mihoko |
| Middle name | |
| Last name | Otake-Matsuura |
Organization
RIKEN
Division name
Center for Advanced Intelligence Project
Zip code
103-0027
Address
Nihonbashi 1-chome Mitsui Building, 15th floor, 1-4-1 Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
TEL
0362252482
mihoko.otake@riken.jp
Public contact
Name of contact person
| 1st name | Mihoko |
| Middle name | |
| Last name | Otake-Matsuura |
Organization
RIKEN
Division name
Center for Advanced Intelligence Project
Zip code
103-0027
Address
Nihonbashi 1-chome Mitsui Building, 15th floor, 1-4-1 Nihonbashi, Chuo-ku, Tokyo 103-0027, Japan
TEL
0362252482
Homepage URL
mihoko.otake@riken.jp
Sponsor or person
Institute
RIKEN Center for Advanced Intelligence Project
Institute
Department
Personal name
Funding Source
Organization
RIKEN Center for Advanced Intelligence Project
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
RIKEN
Address
2-1 Hirosawa, Wako, Saitama, 351-0198, Japan
Tel
050-3500-7242
human@riken.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
Individual participant data that underline the results in the article after deidentification, will be available after publication.
IPD sharing Plan description
Individual participant data and the document (study protocol) that underline the results in the article after deidentification, will be available.
The data sharing will begin following article publication.No end date.
The researchers who provide a methodologically sound proposal can access the data to achieve the aims in the approved proposal.
Proposals should be directed to the email of the principal investigator (Mihoko Otake-Matsuura).
To gain access, data requestors will need to sign a data access agreement.
The data is being considered for availability at third-party registrations. (eg., database of RIKEN, National Institute for Japanese Language and Linguistics, and Informatics Research Data Repository).
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 22 | Day |
Last modified on
| 2023 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053864
